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3239
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2789
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465
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2381
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4099
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3763
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790
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776
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15
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1580
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876
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495
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166
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725
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689
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533
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519
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489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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400
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Screw, Fixation, Bone
392
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Manufacturers
US
Antibodies, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Antibodies, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 1977
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Antibodies, Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 01, 1982
CORTISOL RIA KIT
K822892
·
CGR
Chemistry
·
34d
Cleared
Dec 19, 1980
AMIKACIN RIA KIT
K802877
·
KLQ
Chemistry
·
32d
Cleared
Sep 04, 1979
TSH RIA KIT
K791217
·
JLW
Chemistry
·
64d
Cleared
Sep 13, 1977
T3 UPTAKE DIAG. KIT
K771585
Chemistry
·
26d
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16
Immunology
8
Chemistry
4
Toxicology
2
Microbiology
2